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NCT ID: NCT02209064 Completed - Clinical trials for Arrhythmias, Cardiac

"EASE" Epicardial Access With the EpiAccess System

EASE2
Start date: December 2013
Phase: N/A
Study type: Interventional

Prospective non-randomized, single arm trial to further evaluate the safety and performance of EpiAccess, the study device, for gaining access to the normal, non-distended pericardial space during epicardial diagnostic or therapeutic (ablation) procedures.

NCT ID: NCT02205814 Completed - Knee Osteoarthritis Clinical Trials

Fasitibant Intra-articular Injection in Patients With Symptomatic Osteoarthritis of the Knee

ALBATROSS-3
Start date: April 2014
Phase: Phase 2
Study type: Interventional

This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm, dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy, safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of fasitibant in patients with symptomatic osteoarthritis (OA) of the knee. Approximately 400 male and female patients 40-80 years old, with BMI < 30 kg/m² and with a clinical diagnosis of symptomatic primary osteoarthritis of the knee will be randomised to a total of 4 treatment arms. Each arm includes a single intra-articular injection of one of three dosages of fasitibant (low, intermediate and high dose) OR placebo. The randomisation ratio will be 1:1:1:1. The primary efficacy variable will be the change of the Western Ontario and McMaster Universities Visual Analogue Scale 3.1 A (WOMAC VA 3.1 A) (total pain) subscore from baseline up to 2 weeks after randomisation. Safety will be assessed by monitoring adverse events and clinical laboratory tests; local tolerability at the injection site will also be assessed. In addition, the population pharmacokinetics and the exposure-response relationship will be evaluated. The individual experimental clinical phase will last up to maximal 15 weeks encompassing 7 planned visits at site, including screening, randomisation, 4 follow-up visits and the End of study visit.

NCT ID: NCT02185911 Completed - Anaemia Clinical Trials

Observational Study of Correction of Anaemia With Darbepoetin Alfa at QM Dosing Interval in Patients With CKD Not on Dialysis

ADAPTATION
Start date: June 2014
Phase: N/A
Study type: Observational

To describe anaemia correction via haemoglobin measurements taken throughout observation period in ESA naive patients with chronic kidney disease initiated on darbepoetin alfa QM

NCT ID: NCT02183974 Completed - Clinical trials for Otitis Media With Effusion

Suitable Method for Routine Diagnostics of EER in Children With Otitis Media With Effusion

Start date: June 2012
Phase: N/A
Study type: Interventional

The aim of the study was detection of pepsin in effusion in children with OME using Peptest as new quick and cheap method of detection and comparison results with results of other studies in which pepsin was detected by more demanding methods. Such a type of study hasn't been done so far.

NCT ID: NCT02183961 Completed - Clinical trials for Otitis Media With Effusion

Three Methods Used in the Diagnosis of EER in Children With OME

Start date: June 2012
Phase: N/A
Study type: Interventional

Detection of extraesophageal reflux (EER) in children with chronic otitis media with effusion (OME) using three different diagnostic methods and selection of the group of patients with severe EER who could potentially benefit from antireflux therapy.

NCT ID: NCT02176876 Completed - Clinical trials for Rheumatoid Arthritis

Safety, Tolerability, and Pharmacokinetics of GS-5745 in Subjects With Rheumatoid Arthritis

Start date: August 2014
Phase: Phase 1
Study type: Interventional

This study is to assess the safety, tolerability, and pharmacokinetics (PK) of multiple infusions of GS-5745 in adults with rheumatoid arthritis (RA). Participants will be randomized in a 4:1 ratio to receive 1 intravenous (IV) infusion of GS-5745 or placebo every 2 weeks, for a total of 3 IV infusions.

NCT ID: NCT02171182 Completed - Clinical trials for Post-operative Peripheral Neuropathic Pain

A Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic Pain

Start date: January 2014
Phase: N/A
Study type: Observational

The aim of this study is to monitor the effectiveness and used dosage of the 8% capsaicin patch in real-life clinical practice in the treatment of post-operative neuropathic pain.

NCT ID: NCT02167815 Completed - Clinical trials for Venous Leg Ulcer (VLU)

A Multicenter, Post Marketing Clinical Follow up (PMCF) Investigation to Evaluate the Performance and Safety of a Soft Silicone Foam Dressing and to Evaluate the Performance of Standard Care in Exuding Venous Leg Ulcers

Start date: May 2014
Phase: N/A
Study type: Interventional

This investigation is a Post Marketing Follow-Up Study for Mepilex XT conducted as part of Mölnlycke Health Care's quality system. The primary objective is to evaluate the performance of the dressing when used as intended on exuding Venous Leg Ulcers (VLUs) in the inflammatory and granulating stages of the wound healing process.

NCT ID: NCT02149108 Completed - Clinical trials for Colorectal Neoplasms

Nintedanib (BIBF 1120) vs Placebo in Refractory Metastatic Colorectal Cancer (LUME-Colon 1)

Start date: September 2014
Phase: Phase 3
Study type: Interventional

The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.

NCT ID: NCT02145468 Completed - Clinical trials for Acute Coronary Syndrome

A Phase 3 Clinical Outcomes Study to Compare the Incidence of Major Adverse Cardiovascular Events in Subjects Presenting With Acute Coronary Syndrome Treated With Losmapimod Compared to Placebo (LATITUDE-TIMI 60)

LATITUDE
Start date: June 3, 2014
Phase: Phase 3
Study type: Interventional

Losmapimod is a new anti-inflammatory medication which potentially may benefit patients with Acute Coronary Syndrome, (ACS), a condition which includes heart attack. There is a growing understanding that the inflammatory response to ACS is integral to the subsequent evolution of plaque instability. Losmapimod inhibits p38 mitogen activated protein kinase (MAPK), an enzyme which may play a central role in inflammation in the setting of heart attack. Inhibition of p38 MAPK may stabilize atherosclerotic plaques, reduce the risk of subsequent plaque rupture, indirectly improve vascular function and prevent subsequent thrombosis, and thus reduce infarct size and the risk of subsequent cardiac events. This study will test whether losmapimod can safely reduce the risk of a subsequent cardiovascular event (such as death, heart attack, or near heart attack requiring urgent treatment ) when started immediately after ACS (specifically, heart attack). Patients who present with heart attack and qualify for the study will be randomly assigned to receive 3 months treatment with either losmapimod twice daily or placebo, which will be administered in addition to the usual standard of care therapies for heart attack. Following the in-hospital period, subjects will return for outpatient visits at 4 and 12 weeks, as well as a follow up visit at 24 weeks.